[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611245":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":25,"centralContacts":29,"locations":34,"responsibleParty":118,"collaborators":24,"id":120,"slug":24,"hasResults":121,"nctId":122,"briefTitle":123,"officialTitle":124,"acronym":24,"eligibilityCriteria":125,"healthyVolunteers":121,"sex":126,"minAge":127,"maxAge":24,"enrollmentInfo":128,"targetDuration":24,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":139,"overallStatus":37,"whyStopped":24,"lastUpdateSubmitDate":156,"lastUpdatePostDateStruct":157,"startDateStruct":160,"completionDateStruct":162,"leadSponsor":164,"locationsCount":165},{"fullName":5,"class":6},"Adcytherix SAS","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase 1a ADCX-020","EXPERIMENTAL","Dose escalation of ADCX-020, intravenous",[13],"Drug: ADCX-020",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 1b: ADCX-020","Dose optimization and expansion of ADCX-020, intravenous",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"DRUG","ADCX-020","ADC",[9,15],null,[26],{"name":27,"affiliation":5,"role":28},"Adcytherix","STUDY_DIRECTOR",[30],{"name":5,"role":31,"phone":32,"phoneExt":24,"email":33},"CONTACT","+31 628839232","clinicaltrials@adcytherix.com",[35,48,54,64,73,83,93,103,112],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":24},"Macquarie University","RECRUITING","Sydney","New South Wales","2109","Australia",{"type":43,"coordinates":44},"Point",[45,46],151.20732,-33.86785,{"lat":46,"lon":45},{"facility":49,"status":37,"city":38,"state":39,"zip":50,"country":41,"cosmosGeoPoint":51,"geoPoint":53,"contacts":24},"Blacktown Hospital","2148",{"type":43,"coordinates":52},[45,46],{"lat":46,"lon":45},{"facility":55,"status":37,"city":56,"state":57,"zip":58,"country":41,"cosmosGeoPoint":59,"geoPoint":63,"contacts":24},"Sunshine Coast University Private Hospital","Birtinya","Queensland","4575",{"type":43,"coordinates":60},[61,62],153.11913,-26.74322,{"lat":62,"lon":61},{"facility":65,"status":37,"city":66,"state":57,"zip":67,"country":41,"cosmosGeoPoint":68,"geoPoint":72,"contacts":24},"Tasman Oncology Research","Southport","4215",{"type":43,"coordinates":69},[70,71],153.39796,-27.96724,{"lat":71,"lon":70},{"facility":74,"status":37,"city":75,"state":76,"zip":77,"country":41,"cosmosGeoPoint":78,"geoPoint":82,"contacts":24},"Cancer Research SA","Adelaide","South Australia","5000",{"type":43,"coordinates":79},[80,81],138.59863,-34.92866,{"lat":81,"lon":80},{"facility":84,"status":37,"city":85,"state":86,"zip":87,"country":41,"cosmosGeoPoint":88,"geoPoint":92,"contacts":24},"Linear Clinical Research","Nedlands","Western Australia","6009",{"type":43,"coordinates":89},[90,91],115.8073,-31.98184,{"lat":91,"lon":90},{"facility":94,"status":37,"city":95,"state":95,"zip":96,"country":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":24},"START Barcelona","Barcelona","08023","Spain",{"type":43,"coordinates":99},[100,101],2.15899,41.38879,{"lat":101,"lon":100},{"facility":104,"status":37,"city":105,"state":105,"zip":106,"country":97,"cosmosGeoPoint":107,"geoPoint":111,"contacts":24},"START Madrid FJD","Madrid","28040",{"type":43,"coordinates":108},[109,110],-3.70256,40.4165,{"lat":110,"lon":109},{"facility":113,"status":37,"city":105,"state":105,"zip":114,"country":97,"cosmosGeoPoint":115,"geoPoint":117,"contacts":24},"START Madrid CIOCC","28050",{"type":43,"coordinates":116},[109,110],{"lat":110,"lon":109},{"type":119,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100611245",false,"NCT07238075","ADCX-020 for the Treatment of Patients With Locally Advanced or Metastatic Cancers","A First-in-human, Multicenter Dose Escalation and Multiple Cohort Expansion Phase 1a\u002Fb Study to Investigate Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ADCX-020 in Participants With Locally Advanced or Metastatic Solid Tumors","Inclusion Criteria:\n\n* Male and female participants ≥ 18 years of age\n* Ph1a: Locally advanced or metastatic solid tumor relapsed or PD following local standard treatments, for which no standard treatment is available\n* Ph1b: Eligible patients should have only received prior lines of systemic therapy according to SoC in the advanced\u002Fmetastatic setting (not counting neoadjuvant\u002Fadjuvant treatment if completed \\>6 months prior to recurrence)\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1\n* Radiologically measurable disease by RECIST v1.1\n* Mandatory adequate tumor tissue sample available\n* Must have recovered from all clinically relevant toxicities from previous cancer therapies (to at least Grade 1, except for alopecia)\n\nExclusion Criteria:\n\n* Known allergies\u002Fhypersensitivity\u002Fintolerance to or contraindication to exatecan, or any excipient\n* Phase 1b: Prior antibody drug conjugate exposure with a topoisomerase 1 inhibitor payload\n* Uncontrolled or significant cardiac disease including left ventricular ejection fraction (LVEF) \\\u003C50%, myocardial infarction or uncontrolled\u002Funstable angina\n* Has clinically active central nervous system (CNS) metastases\n* Has a history of lung fibrosis or non-infectious interstitial lung disease (ILD)\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at screening\n* Active corneal disease, or history of corneal disease within 12 months prior to enrollment\n* Other unacceptable abnormalities, medications or procedures as defined by protocol","ALL","18 Years",{"count":129,"type":130},290,"ESTIMATED","INTERVENTIONAL",[133],"PHASE1","The purpose of this first-in-human study is to explore the safety, pharmacokinetics and effects of the study drug ADCX-020 in patients with advanced and metastatic solid tumors. ADCX-020 is an investigational anticancer therapy called antibody drug conjugate.\n\nThis study is set up in multiple parts. In the first part of the study, participants receive increasing doses of ADCX-020. Then 2 or more doses will be assessed to identify the optimal dose. This optimal dose is subsequently evaluated for effect on different cancer types.",[136,137,138],"Advanced Malignancy","Advanced Solid Cancers","Metastatic Solid Tumors",[140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155],"Antibody Drug Conjugate","Antineoplastic Agents","Monoclonal Antibodies","Neoplasms","Response Evaluation Criteria in Solid Tumors (RECIST)","Phase 1 clinical trial","Maximum Tolerated Dose","Open-Label Trials","Multicenter Study","Pharmacokinetics","Pharmacodynamics","Drug-Related Side Effects and Adverse Reactions","Dose-Response Relationship, Drug","Adults","Progression-Free Survival \u002F Overall Survival","Overall response rate","2026-06-05",{"date":158,"type":159},"2026-06-08","ACTUAL",{"date":161,"type":159},"2026-02-23",{"date":163,"type":130},"2029-11-30",{"name":5,"class":6},9]